Caring for women with pelvic floor disorders has become an increasingly important component of women's healthcare. These disorders, which include urinary and faecal incontinence, sexual dysfunction as well as pelvic organ prolapse, affect a large segment of the adult female population. One common cause is trauma during vaginal delivery which may result in a variety of pelvic floor complaints; urinary stress and urge incontinence and faecal incontinence are the most frequent and long lasting. Ultimately conditions associated with pelvic floor disorders may have a significant impact on the lives of women and may require corrective surgery, which is costly and undesirable and in some instances not totally effective.
There is an increasing emphasis on seeking to avoid such detrimental outcomes through the use of various approaches to controlling and improving pelvic floor muscle function through regular or programmed periods of pelvic floor muscle exercise.
A variety of non-surgical approaches have been investigated as treatments of urinary incontinence, including various forms of PFME, biofeedback techniques based on measuring the physical performance of the muscles and muscle strength, other behavioral therapies, and through neuromuscular electrical stimulation (NMES) of the pelvic floor muscles.
NMES involves the electrical stimulation of the pelvic floor muscles using a probe or skin electrodes connected to a device for controlling the electrical stimulation. People receiving NMES may undergo treatments in a clinical setting such as a hospital, or may undergo initial training in a clinician's office followed by home treatment with a rented or purchased pelvic floor stimulator that has been programmed to their perceived needs by the clinician. A trained clinician will be able to assess the type of incontinence and the function of the pelvic floor muscles of an individual woman and be able to programme the stimulation unit to deliver an individualized treatment. A significant limitation of conventional stimulation units is that they use rigid vaginal electrodes and in order to retain the electrode during treatment the woman needs to remain still, and dependent upon the electrode often in a recumbent position. The electrode is commonly hard-wired to an external control unit or in some cases it can be wirelessly connected to an external control unit. However, the need to be connected to the control unit in some way also restricts the freedom to move around during treatment. These factors have a negative impact on the adherence of women to using conventional NMES treatment.
Home use or user controllable electro-stimulation devices have similar problems. Such devices typically have controls that allow the user to set and operate the electro-stimulation device. User control and adjustment of the electro-stimulation is conventionally provided by electronic push switches and or rotational control knobs for various parameters for the electro-stimulation. These means of control are typically either located on the surface of the stimulation device or probe and are exposed from the body during use of the device or they are located on a control unit exterior to the user's body and connected, via a cable or wirelessly, to a stimulation probe located within the user's body. The use of such devices with controls is problematic because most non-expert users find it very difficult to control the device and to optimize the settings for effective electro-stimulation of their pelvic floor muscles. Typically, these units come with a choice of pre-set programmes relating to the type of incontinence. If used without clinician input, there is a risk that the woman does not understand her condition sufficiently well enough to be able to select the correct programme. Due to the nature of NMES applied externally to muscles, typically the sensory nerves respond to the stimulation prior to the motor nerves which produce the contraction. A woman using a home NMES device is therefore at risk of sensing the stimulation at the first sensory level and in assuming that this is the therapeutic level never reaches a motor effect and the true therapeutic level thus resulting in ineffective treatment.
Conventional NMES units, whether used with a clinician or at home by the user, do not have automatic adjustment. Whilst the intensity level, typically voltage, can be manually changed for comfort or to improve the level of contraction typically this would only occur a few times during a treatment (if at all) and typically on an ad hoc basis.
Thus a major challenge with these conventional devices and conventional exercise regimens is to achieve an effective exercise level and/or to achieve a reasonable level of adherence in order to realize the benefits of the exercise, whilst reducing the negative impacts on user's time and lifestyles. In order to address this issue attempts have been made to develop electro-stimulation devices for pelvic floor exercise that are much easier to use, do not require physician or therapist engagement and which do not require any adjustment or control of the electro-stimulation exercise program by the user before or during use.
Examples of such devices are as described in WO2007/059988 and WO2007/059989. In these devices a pre-determined operation voltage and treatment/exercise cycle of pulse frequencies and patterns are programmed into a microchip, which is located within the body of the device and the whole device is inserted into the vagina with closure of the introitus to the vagina.
Whilst such devices are a significant improvement over more conventional prior art devices and regimens there is a need for further improvement to secure effective exercise of the pelvic floor muscles in particular and especially when users are mobile and for a wide range of potential users.